BEUDAMED
    FDA Enforcement Class II Terminated

    Novation Press-Fit Splined, Standard Offset, HA Coated, 12/14 Taper, Size 11, Femoral Stem; Catalog Number 160-30-11; For use in primary total hip arthroplasty.

    Recall: Z-1905-2016 · Reported June 8, 2016

    Enforcement

    Recall Number
    Z-1905-2016
    Event ID
    73200
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Exactech, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 8, 2016
    Initiation Date
    April 12, 2016
    Classification Date
    June 2, 2016
    Termination Date
    July 24, 2019
    Address
    2320 NW 66th Ct, N/A, Gainesville, FL, 32653-1630, United States

    Description

    Novation Press-Fit Splined, Standard Offset, HA Coated, 12/14 Taper, Size 11, Femoral Stem; Catalog Number 160-30-11; For use in primary total hip arthroplasty.

    Reason

    Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.

    Code Info

    Product Codes: LPH, MEH, LWJ, JDI; Catalog Number 160-30-11, Serial Numbers: 4273184, 4273185, 4273187, 4273188, 4273189, 4273190, 4273191, 4273192 and 4273186, Exp. 2/8/2021.

    Distribution

    Distributed in FL, NJ, NY, OH, OK, RI, TN, VA and HI.

    Quantity

    9 devices.